Time’s up: what happens when genetics patents run out?

NASHVILLE, Tenn. — Patents are coming off of the original genetically modified crops, but the responsibilities for those genetics and technologies remain.

The first GM crop was commercialized in 1996 with the placement of the glyphosate tolerant gene.

The first GM biotech patent in Canada expired last year when Roundup Ready soybeans lost some of their patent protection. The same U.S. patent will expire in 2014, and other patents will soon follow.

The American Seed Trade Association (ASTA) is preparing to put controls on those genetics as the patents expire.

“Maintaining our exports is a big driver here,” said Bernice Slutsky of the association while attending the Commodity Classic in Nashville.

“Having a non-approved event in a commodity shipment is a serious issue. We need to be able to provide high quality export products.”

The association is hoping to avoid accidents or misuse of those genetics tools in the future.

“We want a framework that will transition from a biotech event to a generic event with an accord agreement. We have a set of principals we have agreed to,” she said.

Under an accord agreement, the seed industry members that own the patented genetics would become part of the accord group, as would anyone who wanted to have access to the off-patent genetics.

The accord would give generic users access to information about the technical processes and responsibilities associated with using the technology and require them to pay compensation to the former patent holder for a data transfer or regulatory maintenance.

Matt O’Mara of the Biotechnology Industry Organization (BIO) said the seed trade association and his group have the same goals.

“Just because an event (the placing of genetic material into a specific site within a genome) loses its patent or a regulatory (constraint) in the United States doesn’t mean it’s going to in other parts of the world at the same time, or ever,” O’Mara said.

“And we depend on exporting to other parts of the world.”

Slutsky said international approval of these technologies can be fickle.

“Regulatory requirements are always evolving,” she said.

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“Maintaining these, such as Korea recently, is a lot of work. We’d like these to be science based, but it isn’t. You need science know-how and political know-how. These aren’t transparent or predictable.”

O’Mara said the cost of maintaining approvals for the use of technology contained in seeds should be the responsibility of those who are profiting from its use, which would include a generic user of the off-patent technology.

“We need a process that reflects these obligations,” he said.

“What we need is for a new seed company (or farmer organization) to take over the responsibility of the authorizations or stewardship.”

One option would be for the originating company to continue that service at a cost.

ASTA and BIO are talking about creating an initial notice that a product will come off of patent. A confidentiality agreement would then be available that allows information to be provided about the product so that an interested party could decide about regulatory maintenance costs, international regulatory costs and costs related to the use of the genetics.

“They need to decide if the event is a good business decision for them,” said O’Mara.

The new user must also be qualified either on their own or as a group to maintain and market the product.

“We see this in generic (pesticides),” said O’Mara.

He said the accord needs to be able to negotiate and assess the residual value of existing global regulatory data and authorizations for the former patent holder.

“A set period of time would have to be in place,” he said.

“Data, authorizations and events are made available or transferred to the entities that assume or share regulatory and stewardship responsibilities, (post patent) expiration.”

Slutsky said in Canada and the U.S. there aren’t maintenance costs for the first patents that expire, but there are internationally.

Monsanto says it plans to maintain the first version of Roundup Ready’s regulatory requirements through 2021.

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ASTA and BIO said the accord is a legal contract with anyone who wants to take part in the generic marketplace.

“It should have a very low threshold cost to get people to enter into the agreement,” Slutsky said.

“If the signatory (former patent holder) agrees and that was a grower group, they might not have a responsibility to the accord, but a seed company would.”

Signatories should be those who intend to commercialize a product contained in the accord, she added.

O’Mara said patent holders have obligations to their data and technology that could extend to liability if an event were to cause a market disruption even after the expiry of patent protection.

ASTA and BIO are meeting in the next month to complete their plans for an accord process.

By the end of 2023, 23 biotechnology patents on plant traits and processes filed before 2006 will expire.

Trish Jordan of Monsanto says that while the first possibility to grow off-patent soybeans will take place in 2013, the canola patents will not expire for several more years.

“There is some time to work out the details,” she said.

Patty Townsend of the Canadian Seed Trade Association said there was an early start to setting up a Canadian industry strategy to deal with what will happen within in the seed business as those patents enter the generic realm.

Despite talks beginning four years ago, there has been little progress.

“We will be watching the American process and talking with our (counterparts) at the ASTA,” she said.

“There might be something that we can all learn from or take part in,” she said.

Pioneer Hi-Bred, like other genetics owners and developers, has taken the position that despite the expiry of one patent on their Roundup Ready soybeans, there are other patents and registrations on their technology that still apply and technology use agreements still apply to their products.

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Steve Schnebly said his company expects most producers will want the latest in yield and stress management technology as it is available and doesn’t see a big rush for growers toward older technologies as patents expire.